STONY BROOK, N.Y. & NEW YORK–(BUSINESS WIRE)–Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and LIM College, a midtown Manhattan-based leader in education for the business of fashion, today announced that Applied DNA will provide COVID-19 surveillance testing for all in-person students, faculty, and staff at LIM College as they return to school for the resumption of in-person classes for the Spring semester, beginning on Feb. 22, 2021.
Testing will be conducted weekly by safeCircle™, the Company’s pooled COVID-19 surveillance testing program. The safeCircle program is powered by the Company’s Linea™ COVID-19 Assay Kit, which the FDA has highlighted for its ability to potentially discriminate for certain variants of SARS-CoV-2, the virus that causes COVID-19. Aggregate testing results will be reported to LIM College administrators via safeCircle’s integration with CLEARED4, the Company’s surveillance testing program partner, through CLEARED4’s smartphone-based online health safety management and reporting solution.
Dr. James A. Hayward, president and CEO, Applied DNA, stated, “safeCircle offers schools an efficient and cost-effective approach to keeping students and educators healthy and safe from COVID-19. We applaud LIM College’s decision to return to in-person learning equipped with the means for administrators to react with speed to any virus spread. LIM College joins other primary, secondary, and higher education institutions relying on safeCircle as their COVID-19 surveillance testing solution to ensure a safe learning environment.”
Commenting on the implementation of safeCircle, LIM College Dean of Student Affairs Michael Richards said, “LIM College has always been committed to creating the safest learning and working environment possible. Now, safeCircle’s surveillance testing will play an indispensable role in allowing us to resume in-person instruction at a time when many other colleges and universities across the country have been forced to pivot away from in-person experiences due to COVID-19.”
About the Linea™ COVID-19 Assay Kit
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostics and testing offering that is the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Applied DNA is a member of the Russell Microcap® Index.
About LIM College
Founded in 1939, LIM College educates students for success in the global business of fashion and its many related industries. As a pioneer in experiential education, LIM College fosters a unique connection between real-world experience and academic study in business principles, offering master’s, bachelor’s and associate degree programs. LIM College is located in three buildings in Manhattan — the nation’s fashion and business capital — giving students vast opportunities for hands-on experience and professional development. Alumni have gone on to excel at top companies, including Amazon, Tommy Hilfiger, John Varvatos, Laura Mercier, the National Football League, and Authentic Brands Group.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020 and Form 10-Q filed on February 11, 2021, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.